Dimethyl fumarate Teva

dimethyl fumarate

Table of contents

Opinion

On 13 October 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dimethyl fumarate Teva, intended for the treatment of multiple sclerosis. The applicant for this medicinal product is TEVA GmbH.

Dimethyl fumarate Teva will be available as 120 mg and 240 mg gastro-resistant hard capsules. The active substance of Dimethyl fumarate Teva is dimethyl fumarate, an immunosuppressant (ATC code: L04AX07). It primarily acts by triggering the activation of the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway.

Dimethyl fumarate Teva is a generic of Tecfidera, which has been authorised in the EU since 30 January 2014. Studies have demonstrated the satisfactory quality of Dimethyl fumarate Teva, and its bioequivalence to the reference product Tecfidera. A question and answer document on generic medicines can be found here.

The full indication is:

Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Dimethyl fumarate Teva
Agency product number
EMEA/H/C/005963
International non-proprietary name (INN) or common name
  • dimethyl fumarate
Active substance
  • dimethyl fumarate
Therapeutic area
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Date opinion adopted
13/10/2022
Company name
Teva GmbH
Status
Positive
Application type
Initial authorisation

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